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Regulatory Affairs Updates 19/20

Medical Devices - Guidelines and Regulations Worldwide


MDR – MDCG update

The European commission has published two additional MDCG Guidance documents last week. MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories.


MDCG 2019-3 Interpretation of Article 54(2) b rev.1 (Exempt devices from the premarket clinical evaluation consultation procedure).


FDA – GUDID Update

The FDA has updated their Data Elements Reference Table and the corresponding HL7 implementation file, which might require adaption of your GUDID upload procedure.


COVID-19

APAC Region EUA Information

Several Countries in the APAC Region are still working on an Emergency Use Authorization (EUA) for Products during the COVID-19 pandemic.


India

Handling of Notarization and apostille could be difficult during the COVID-19 situation. The applicant may submit application for import license with such document which is self-attested and will be submitted notarized or apostilled later.


Saudi Arabia

The SFDA has updated and published some guidance documents:

  • MDS-G47 Guidance on Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – Recognized Standards
    PDF download
  • Guidance on General Requirements for Medical Devices Manufacturing
    PDF download
  • MDS – G46 Guidance on Requirements for Medical Masks - Recognized Standards
    PDF download

Japan

PMDA implemented an organizational restructuring of Office of International Programs on April 1, 2020.


Taiwan

The Taiwan FDA published a set of pdf files for the draft of "Setting Standards for Medical Device Manufacturers" in May 2020.

  • Announcement of Medical Equipment Manufacturers Setting Draft Standards PDF download
  • General Explanation of Draft Standards Set by Medical Device Manufacturers PDF download
  • The medical equipment manufacturers set the draft standards one by one
    PDF download

Malaysia

The Ministry of Health Malaysia has published DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT “MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION” for public comment.

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All updates compiled in one PDF file:

You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.

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